Blood Pressure, Cardiovascular Disease, Growth, Metabolic Syndrome, Obesity
Conditions
Keywords
Children, Complementary feeding, Breast feeding, Cow's milk, Formula, Protein, LCPUFA, Fish oil, Lipid profile, Intestinal inflammation, Intestinal microbiota
Brief summary
The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.
Interventions
BEHAVIORALCow's milk with fish oil
BEHAVIORALCow's milk without fish oil
BEHAVIORALFormula with fish oil
BEHAVIORALFormula without fish oil
Sponsors
Anjo A/S
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
8 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
* Singleton infants * Born \>= 37 wk of gestation * Birth weight \> 2500g * \>= 5th percentile for gestational age * A 5-min Apgar score \>= 7 * Daily consumption of cow's milk or formula
Exclusion criteria
* No major complications at birth or in fetal life * No chronic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth | — |
| Body composition (weight, length, knee-heel-length, waist, head, and arm circumference, skin fold measurements). | — |
| IGF-I | — |
| IGFBP-3 | — |
| Insulin - glucose metabolism (HOMA index). | — |
| Urea Nitrogen | — |
| Albumin | — |
| C-peptide | — |
| Amino Acids | — |
| Erythrocyte fatty acid composition | — |
| Blood pressure | — |
| Lipid Profile | — |
| Heart Rate Variability (HRV) | — |
| In vitro cytokine production from stimulated full blood (IL-10, IFN-gamma, TNF-alpha) | — |
| Plasma IgE, IL-2R, and CRP | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of cholesterol and triglycerides | — |
| Allergy status | — |
| Cognitive test (The infant means-end problem solving test) | — |
| Iron status (hemoglobin, ferritin and transferrin receptors) | — |
| Feces samples: Calprotectin, IgA and composition of the intestinal microbiota | — |
Outcome results
None listed